Cognitive Training and Enhanced Supported Employment in Schizophrenia

NCT ID: NCT00339170

Last Updated: 2020-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-04-30

Study Completion Date

2013-07-31

Brief Summary

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This study will evaluate the effectiveness of a computer-based cognitive enhancement program plus a work therapy program at improving productivity, work performance, and quality of life in schizophrenic individuals.

Detailed Description

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Schizophrenia is a chronic, severe, and disabling brain disorder that affects 2.4 million people in the United States. Individuals with schizophrenia may have difficulties with cognitive functioning, including problems with attention, memory, and organizational thought processes. These factors can lead to decreased productivity and poor work performance, which may make holding a job difficult. Research has shown that certain types of psychological therapies, such as cognitive behavioral therapy, are useful in reducing the severity of schizophrenic symptoms. The purpose of this study is to determine whether a computer-based cognitive enhancement training program, in combination with a work therapy program, will enhance workplace performance, productivity, and quality of life in individuals with schizophrenia.

This study will enroll individuals with schizophrenia or schizoaffective disorder. Participants will undergo a cognitive assessment at baseline. They will then be randomly assigned to either a 12-month cognitive enhancement training program plus a 12-month work therapy program or a 12-month work therapy program alone. Participants in the cognitive enhancement training program will receive feedback on their cognitive strengths and weaknesses based on the outcomes of the baseline assessment. The training component will be comprised of 150 computer-based exercises that focus on improving memory, attention, and organizational skills. Participants will attend two weekly meetings: one will focus on providing feedback regarding goal-setting and problem-solving, and the other will focus on improving verbal skills and social information processing. Individuals taking part only in the work therapy program will attend two non-cognitive discussion groups per week. All participants will work up to 20 hours a week in an approved work environment, and will have access to appropriate support services. Following the end of the program, participants will have the option of working an additional 12 months. Schizophrenia symptoms, quality of life, and neuropsychological and rehabilitation effects will be assessed at the end of Years 1 and 2.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Participants receive a 12-month cognitive enhancement training program plus a 12-month work therapy program.

Group Type EXPERIMENTAL

Computer-Based Cognitive Enhancement Training Program

Intervention Type BEHAVIORAL

Participants in the cognitive enhancement training program will receive feedback on their cognitive strengths and weaknesses based on the outcomes of the baseline assessment. The training component will be comprised of 150 computer-based exercises that focus on improving memory, attention, and organizational skills. Participants will attend two weekly meetings: one will focus on providing feedback regarding goal-setting and problem-solving, and the other will focus on improving verbal skills and social information processing.

Work Therapy Program

Intervention Type BEHAVIORAL

Participants in the work therapy program will attend two non-cognitive discussion groups per week.

2

Participants receive a 12-month work therapy program alone.

Group Type ACTIVE_COMPARATOR

Work Therapy Program

Intervention Type BEHAVIORAL

Participants in the work therapy program will attend two non-cognitive discussion groups per week.

Interventions

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Computer-Based Cognitive Enhancement Training Program

Participants in the cognitive enhancement training program will receive feedback on their cognitive strengths and weaknesses based on the outcomes of the baseline assessment. The training component will be comprised of 150 computer-based exercises that focus on improving memory, attention, and organizational skills. Participants will attend two weekly meetings: one will focus on providing feedback regarding goal-setting and problem-solving, and the other will focus on improving verbal skills and social information processing.

Intervention Type BEHAVIORAL

Work Therapy Program

Participants in the work therapy program will attend two non-cognitive discussion groups per week.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of schizophrenia or schizoaffective disorder

Exclusion Criteria

* Hospitalized in the 30 days prior to study entry
* Homeless in the 30 days prior to study entry
* Changed medications in the 30 days prior to study entry
* Substance abuse in the 30 days prior to study entry
* History of head trauma
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Morris D. Bell, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University School of Medicine, VA CT Healthcare System

Locations

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Connecticut Mental Health Center

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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Bell, M.D., Bryson, G., Kaplan, E. Work rehabilitation in schizophrenia: cognitive predictors of best and worst performance. Schizophrenia Research. 1999; 36:322.

Reference Type BACKGROUND

Bell M, Bryson G, Wexler BE. Cognitive remediation of working memory deficits: durability of training effects in severely impaired and less severely impaired schizophrenia. Acta Psychiatr Scand. 2003 Aug;108(2):101-9. doi: 10.1034/j.1600-0447.2003.00090.x.

Reference Type BACKGROUND
PMID: 12823166 (View on PubMed)

Bell M, Bryson G, Greig T, Corcoran C, Wexler BE. Neurocognitive enhancement therapy with work therapy: effects on neuropsychological test performance. Arch Gen Psychiatry. 2001 Aug;58(8):763-8. doi: 10.1001/archpsyc.58.8.763.

Reference Type BACKGROUND
PMID: 11483142 (View on PubMed)

Bell MD, Fiszdon J, Bryson G, Wexler BE. Effects of neurocognitive enhancement therapy in schizophrenia: normalisation of memory performance. Cogn Neuropsychiatry. 2004 Aug;9(3):199-211. doi: 10.1080/13546800344000084.

Reference Type BACKGROUND
PMID: 16571581 (View on PubMed)

Greig T, Zito W, Bell MD. Rehab rounds: A hybrid transitional and supported employment program. Psychiatr Serv. 2004 Mar;55(3):240-2. doi: 10.1176/appi.ps.55.3.240. No abstract available.

Reference Type BACKGROUND
PMID: 15001722 (View on PubMed)

Bell, M.D., Brsyon, G.J. Work rehabilitation in schizophrenia: cognitive predictors of best and worst performance. Schizophrenia Research. 2001;36:322.

Reference Type BACKGROUND

Bell, M.D, Brsyon, G.J , Fiszdon, J., Greig, T.C., Wexler, B.E. Neurocognitive enhancement therapy and work therapy in schizophrenia: Work outcomes at 6 months and 12 month follow-up. Biological Psychiatry. 2004; 55: 1S-242S.

Reference Type BACKGROUND

Greig, T.C., Nicholls, S.S., Bryson, G.J., Bell, M.D. The Vocational Cognitive Rating Scale: A Scale for the Assessment of Cognitive Functioning at Work for Clients With Severe Mental Illness. The Journal of Vocational Rehabilitation. 2004; 21: 71-81.

Reference Type BACKGROUND

Bryson, G & Bell, MD. Work performance improvement in schizophrenia: Symptom and cognitive predictors. Schizophrenia Resarch. 2001; 49: 258.

Reference Type BACKGROUND

Bell MD, Choi KH, Dyer C, Wexler BE. Benefits of cognitive remediation and supported employment for schizophrenia patients with poor community functioning. Psychiatr Serv. 2014 Apr 1;65(4):469-75. doi: 10.1176/appi.ps.201200505.

Reference Type DERIVED
PMID: 24382594 (View on PubMed)

Surti TS, Corbera S, Bell MD, Wexler BE. Successful computer-based visual training specifically predicts visual memory enhancement over verbal memory improvement in schizophrenia. Schizophr Res. 2011 Nov;132(2-3):131-4. doi: 10.1016/j.schres.2011.06.031. Epub 2011 Jul 27.

Reference Type DERIVED
PMID: 21795025 (View on PubMed)

Other Identifiers

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R01MH061493

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR AT-RH

Identifier Type: -

Identifier Source: secondary_id

R01MH061493

Identifier Type: NIH

Identifier Source: org_study_id

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